| CTRI Number |
CTRI/2025/03/083334 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
randomized comparative clinical trial on the efficacy of ajeet agad and siddharthak agad along with amrut sarpi in tobacco chewing addiction withdrawal symptoms |
|
Scientific Title of Study
|
randomized comparative clinical trial on the efficacy of ajeet agad and siddharthak agad along with amrut sarpi in tobacco chewing addiction withdrawal symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHEETAL BHATTOTIA |
| Designation |
PG SCHOLAR |
| Affiliation |
DsRRAU, Jodhpur |
| Address |
MMM GOVERNMENT AYURVEDA COLLEGE, UDAIPUR, RAJASTHAN
425, teachers colony, ambamata, udaipur. pin code 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
7014688180 |
| Fax |
|
| Email |
SHEETALBHATTOTIA123@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. PAPPU LAL SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
MMM GOVERNMENT AYURVEDA COLLEGE, UDAIPUR, RAJASTHAN affiliated by DsRRAU, Jodhpur |
| Address |
MMM GOVERNMENT AYURVEDA COLLEGE, UDAIPUR, RAJASTHAN
college quarters, MMM government ayurved college, udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9783023473 |
| Fax |
|
| Email |
DRPAPPULAL@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
PAPPU LAL SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
MMM GOVERNMENT AYURVEDA COLLEGE, UDAIPUR, RAJASTHAN |
| Address |
MMM GOVERNMENT AYURVEDA COLLEGE, UDAIPUR, RAJASTHAN
COLLEGE QUARTERS, MMM GOVERNMENT AYURVED COLLEGE, UDAIPUR
Udaipur
RAJASTHAN
313001
India |
| Phone |
9783023473 |
| Fax |
|
| Email |
DRPAPPULAL@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| mmm government ayurveda college, udaipur, rajasthan OR By Self |
|
|
Primary Sponsor
|
| Name |
MMM GOVERNMENT AYURVEDA COLLEGE UDAIPUR RAJASTHAN |
| Address |
AMBAMATA SCHEME A- RD RADAJI CIRCLE UDAIPUR RAJASTHAN |
| Type of Sponsor |
Other [GOVERNMENT AYURVEDA COLLEGE] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| sheetal bhattotia |
government ayurveda hospital motichohhatah |
opd no 23 government ayurved hospital, moti chohhatta attached with mmm government ayurveda college, udaipur,
Udaipur
RAJASTHAN |
7014688180
SHEETALBHATTOTIA123@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee mmm government ayurveda college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: MADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ajeet agad, Reference: sushrut kalp 5/ 63-64, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -(2) Medicine Name: amrut sarpi, Reference: sushrut kalp 6/12-13, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: siddhartak agad, Reference: charak chikitsa 9/69-72, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -(2) Medicine Name: amrut sarpi, Reference: sushrut kalp 6/12-13, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosed patient of tobacco and other similar products ex khaini, zarda, pan masala or gutka chewing addiction.
2)Clinical manifestation of tobacco withdrawal patient including craving for nicotine, anxiety, depression. restlessness etc. which will be presented at that time.
3) Patient willing to give consent for clinical trial.
4) Patients having history of Tobacco chewing addiction of at least one year. |
|
| ExclusionCriteria |
| Details |
1) Tobacco addicted patient suffering from cancer of lung, oral cavity, larynx, and esophagus.
2) Tobacco addicted patients who are suffering from major psychiatric disorders.
3) Tobacco addicted patients suffering from major systemic illness like myocardial infarction, ischemic heart disease, pulmonary tuberculosis etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in clinical manifestation of tobacco chewing withdrawal symptoms |
on 16, 31, 46th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in FTND - ST parameters of tobacco chewing withdrawal symptoms |
16, 31, 46th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
tobacco addiction became a major health problem throughout world. modern drugs for tobacco withdrawal such as nicotine gums, trandermal patch, etc are likely to give new addiction so here ayurvedic formulation are selected which do not cause such problems. ayurvedic approach in tobacco addiction is less explored so an attempt has been made to study tobacco addiction. |